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Completed

NCT Number: NCT03892460

Transitional Rehabilitation in CABG Patients

The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

About this study

Coronary artery bypass graft (CABG) surgery is a common surgical procedures and an important treatment option for coronary artery disease. The post-surgery period of rest and recovery is associated with cardiorespiratory and skeletal muscle deconditioning. The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can serve as a bridge between surgery and the start of cardiac rehabilitation to preserve or improve physical function. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated prior to CABG, upon discharge and 4 weeks Post-CABG surgery. Assessments will include measurements of physical function by the Short Physical Performance Battery, 6 min walk tests and body composition analysis, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36. Additionally, accelerometry will be used to monitor weight-bearing physical activity during the 4 week treatment phase.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50-80 yrs of age
  • ambulatory
  • scheduled for coronary artery bypass graft surgery
  • able to provide informed consent

Exclusion criteria

  • rheumatoid arthritis or other inflammatory/autoimmune disease
  • cancer, excluding non-melanoma skin cancer
  • exercise limiting peripheral vascular disease
  • neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event
  • body mass index >38 kg/m2
  • valvular heart disease not corrected surgically
  • lower extremity blood clot or implantable cardioverter-defibrillator

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

bilateral quadriceps exercise with neuromuscular electrical stimulation

Primary outcomes

  1. Short Physical Performance Battery

    Time frame: 4 weeks

    Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.

Secondary outcomes

  1. 6 Minute Walk Distance

    Time frame: 4 weeks

    6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in cardiac surgery patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course.

  2. Medical Outcomes Short Form 36 - Physical Function

    Time frame: Hospital discharge and 4-weeks post-discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in physical function due to health problems. Lower scores represent more physical function disability, while higher scores represent less disability.

  3. Medical Outcome Short Form 36 - Role Physical

    Time frame: Hospital discharge and 4-weeks post-discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in usual role activities because of physical health problems. Lower scores represent more disability, while higher scores represent less disability.

  4. Medical Outcomes Short Form 36 - Bodily Pain

    Time frame: Hospital discharge and 4-week post-discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on bodily pain. Lower scores represent more pain, while higher scores represent less pain.

  5. Medical Outcomes Short Form 36 - General Health

    Time frame: Hospital discharge and 4-week post-discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.

  6. Medical Outcomes Short Form 36 - Vitality

    Time frame: Hospital discharge and 4-weeks post-discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on vitality (energy and fatigue). Lower scores represent less vitality, while higher scores represent more vitality.

  7. Medical Outcomes Short Form 36 - Social Function

    Time frame: Hospital discharge and 4-weeks post-discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in social activities because of physical or emotional problems. Lower scores represent more more limitations, while higher scores represent less lmitations.

  8. Medical Outcomes Short Form 36 - Role Emotional

    Time frame: Hospital discharge and 4-week discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in usual role activities because of emotional problems. Lower scores represent more limitations, while higher scores represent less limitations.

  9. Medical Outcomes Short Form 36

    Time frame: Hospital discharge and 4-week post-discharge

    The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This measure represents the total computed score across all sub-domains. Lower scores represent worse overall health, while higher scores represent better health.

  10. Physical Activity

    Time frame: Daily from discharge to 4-week post-discharge evaluation

    Physical activity was measured throughout the intervention in control and treatment groups and data. Data were analyzed by regression analysis to obtain the best fit line for the data and to compute a slope of the change in step count with day post-discharge to examine whether groups differed in their rate of recovery of weight-bearing activity (ie, walking).

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2019
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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